Principal - Engineer - Process (Critical Utilities)
Eli Lilly and Company
Summary
Lilly is constructing an advanced manufacturing facility in Houston, TX, to produce API (Active Pharmaceutical Ingredient) molecules. The site will supply APIs for current and future products, including new modalities. This is a chance to join the startup team for a greenfield manufacturing site. The successful candidate will help build the processes and facility that carry the site into GMP manufacturing operations.
Job description
We are seeking a Principal Process Engineer for Critical Utilities to support the API manufacturing business in Houston. This engineer will be responsible for critical utilities in a GMP environment, including GMP water pre-treatment, generation, storage and distribution, along with other utility systems that support manufacturing. The role is core to delivering our product pipeline across batch and continuous API production and development.
Responsibilities
Facility Start-Up
- Provide engineering support to the Global Facility Delivery Team with a strong focus on right first time and on schedule facility start-up, including design reviews, process safety assessments, user requirements, C&Q support, unit operation shakedown and start-up, and facility operational readiness.
- Contribute to the integrated operational readiness plan and own assigned elements such as SOP development, maintenance strategy, automation optimization, pre-startup safety reviews, alarm requirements, and performance qualification requirements and protocol development.
- Own the qualified state of equipment for assigned systems.
- Develop and implement unit operation and equipment control strategy to sustain and optimize critical utilities systems in support of manufacturing operations.
- Support initial operations training as the equipment and area SME for assigned systems.
Facility Operations
- Provide engineering support in critical utilities operations through application of chemical and/or mechanical engineering fundamentals.
- Monitor, assess and document equipment performance to maintain ongoing qualification.
- Support development and maintenance of the basis of safety for equipment as required.
- Apply mechanistic modelling, process simulation and analysis to enhance process understanding and control.
- Identify and implement continuous improvement opportunities related to equipment and processes as a core member of the cross-functional process team.
- Use root cause analysis techniques to investigate process and equipment issues and deliver robust and sustainable corrective and preventative actions.
- Collaborate with maintenance teams to plan and execute scheduled maintenance activities, including equipment calibration and testing.
Additional Skills/Preferences
- Experience in Pharmaceutical or Chemical Manufacturing.
- Deep technical interest and understanding in the field of chemical engineering.
- Strong analytical and problem-solving skills.
- Working knowledge of GMP utility systems such as purified water, water for injection, clean steam, or process gases.
- Exposure to facility start-up, commissioning and qualification, or operational readiness work.
- Ability to work on own initiative and as part of a process team consisting of a diverse group of management, production, science and engineering professionals.
- Creativity to identify improvement opportunities and the tenacity/initiative to see them implemented.
- Guidance/mentoring of others through processes.
- Flexibility to meet business needs.
Other Information
Occasional travel required, 5 to 10%. Required to be working onsite. Required to be on-call. Occasional shift work may apply.
Requirements
- Bachelor's degree in engineering
- 3+ years of relevant experience in manufacturing operations
- Must be authorized to work in the United States on a full-time basis
- No sponsorship for work authorization or visas (including F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, L-1)
Benefits
- 401(k) Matching
- Pension
- Vacation Benefits
- Medical, Dental & Vision
- Prescription Drug Benefits
- Flexible Spending Accounts
- Life Insurance
- Death Benefits
- Employee Assistance Program
- Fitness Benefits
- Employee Clubs & Activities
- Company Bonus
Company overview
Eli Lilly and Company, commonly known as Lilly, is a leading American multinational pharmaceutical corporation headquartered in Indianapolis, Indiana. Founded in 1876 by Colonel Eli Lilly, the company has grown into one of the world's most valuable pharmaceutical enterprises, with operations in approximately 125 countries. Lilly specializes in developing and manufacturing innovative medicines across multiple therapeutic areas, including diabetes, oncology, neuroscience, immunology, and cardiometabolic diseases. The company is renowned for its groundbreaking work in insulin production, having been the first to mass-produce insulin and later developing the first commercially available insulin product in the U.S. Lilly's current portfolio includes blockbuster medications such as Mounjaro and Zepbound (tirzepatide) for diabetes and obesity, Trulicity (dulaglutide) for type 2 diabetes, Verzenio (abemaciclib) for breast cancer, and Taltz (ixekizumab) for autoimmune conditions. With approximately 47,000 employees worldwide, Lilly maintains a strong commitment to research and development, investing heavily in scientific innovation to address some of the world's most significant health challenges. The company operates with a mission to make life better for people around the world through the discovery and delivery of innovative medicines.